Ampio Pharmaceuticals, Inc. (AMPE) on Q2 2021 Results - Earnings Call Transcript
Operator: Thank you, and welcome to the Ampio Pharmaceuticals 2021 Second Quarter Earnings Result and Corporate Update Webinar. As a reminder, this call is being recorded. At this time, I would like to turn the floor over to Mr. Dan Stokely. Dan, please.
Dan Stokely: Thank you very much, Catherine. And I hope everyone's having a great day. It's our pleasure, me and the rest of the Ampio executive management team, to be present here today. And we'd like to thank each one of you for attending our second quarter 2021 financial results and business update call either via phone or the webcast. Prior to reading the safe harbor forward-looking statement, I'd like to introduce you to the members of the executive management team of Ampio Pharmaceuticals, who will be presenting and/or participating on the call today. First, here with us at the company headquarters in Englewood, Colorado, is Mr. Mike Macaluso, the Chairman and Chief Executive Officer. We also have present, Dr. David Bar-Or, Director and Founder; Holli Cherevka, the company's Chief Operating Officer; and me, Dan Stokely, the Chief Financial Officer. I'd like to start out first reading our safe harbor statement. These slides and materials, which today, but including also and accompanying oral presentation, may contain forward-looking statements about our business. You should not place undue reliance on forward-looking statements as these statements are based upon our current expectations, forecasts and assumptions and are subject to significant risks and uncertainties. These statements may be identified by words such as may, will, should, could, expect, intend, plan, anticipate, believe, estimate, predict, potential, forecast, continue or the negative of these terms or words or terms of similar meaning. Risks and uncertainties that could cause our actual results to differ materially from those set forth in any forward-looking statements include, but are not limited to, the matters listed under the heading Risk Factors and our Annual Report on Form 10-K for the year ended December 31, 2020, which is on file with the Securities and Exchange Commission as well as other risks detailed in our subsequent filings with the Securities and Exchange Commission. These reports are available at www.sec.gov. Finally, statements and information in this presentation, including forward-looking statements, speak only as of the date they are made or provided unless earlier data is indicated. And we do not undertake any obligation to publicly update any statements or information, including forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Now that we have all this out of our way, I'd like to discuss our financial results for the second quarter period ending June 30th, 2021. Cash and cash equivalents totaled $20.5 million on June 30th, 2021 compared to $17.3 million on December 31st, 2020. Increase of $3.2 million is primarily attributable to net proceeds that the company received from the utilization of our aftermarket or ATM equity offering of about $9.5 million, which represents about 5.9 million shares at an average stock price of $1.69 a share, which was partially offset by cash required to fund the business operations totaling $6.5 million. We recognize a net loss of $3.6 million for the three months ended June 30, 2021, compared to a net loss of $2.7 for the three months ended June 30, 2020. The net loss during the 2021 quarter was primarily attributable to operating expenses of $3.7 million; partially offset by the non-cash modest derivative gain of $0.1 million. The net loss for the 2020 quarter was primarily attributable to operating expenses of $2.6 million and the non-cash derivative loss of $0.7 million; partially offset by the gain accompanying recognized from the forgiveness of PPP loan of $0.5 million. Operating expenses increased $1.1 million for the 2021 quarter as compared to the 2020 quarter primarily due to a $1.2 million increase in research and development costs, partially offset by a $0.1 million decrease in G&A costs. We recognized a net loss for the $7.2 million for the six months ended June 30, 2021 compared to a net loss of $7.9 million for the six months ended June 30, 2020. The net loss during the 2021 period was primarily attributable to operating expenses of $7.5 million that was partially offset by derivative gain of $0.3 million. And the net loss during the 2020 period was primarily attributable to operating expenses of $8.6 million, partially offset by the gain realized from the forgiveness of the PPP loan of $0.5 million and non-cash derivative gain of $0.2 million. The operating expenses decreased $1.1 million from the 2020 period to the 2021 period due to a $0.8 million decrease in research and development costs and a $0.3 million decrease in G&A costs. Moving on, research and development expenses for the three months period ended June 30, 2021 were 2.3 million, which reflects an increase of 1.2 million or 103% from operating expenses for the same period in 2020. And which were consistent with expenses for the first quarter of 2021. The increase of $1.2 million compared with second quarter 2020 is primarily due to the incremental costs incurred from contracting in CRO efforts to clean scrub and secure the AP-013 database. In addition, during the current period, the company incurred incremental costs associated with several new trials, AP-017, AP-018 and AP-019 trials and pre clinical research studies that were not present in the second quarter of 2020. R&D expenses for the six months ended June 30, 2021 decreased $0.8 million or 15% from R&D expenses for the six months ended June 30, 2020. The decrease is primarily attributable to an overall decrease in clinical trials sponsored research expenses in the current period totaling $1.4 million, which was attributable to the pause of the AP-013 study in April of 2020, which was partially offset by incremental costs incurred during the current period associated with the CRO efforts that were aligned to clean scrub and security AP-013 database and also from incremental costs associated with new trials that were started in the current period. G&A expenses for the three months ended June 30, 2021, decreased $0.1 million or 6% from total G&A expenses for the three months ended June 30, 2020. And for the six months ended June 30, 2021, the expenses decreased $0.3 million or 10% from G&A expenses for the six months ended June 30, 2020. For both periods, the decrease is attributable to an overall decrease in litigation-related legal costs as a result of the dismissal of the securities class action and derivative cases during the third quarter of 2020. Total shares of common stock outstanding were 200,070,419 shares on June 30, 2021, compared to 193,378,996 on December 31, 2020. The increase during the six month period ending June 30, 2021, is attributable to a, issuance of shares under the ATM equity program, totaling approximately 5.9 million shares, and some nominal issuance of our surrendering warrant and stock options, totaling $9 million shares. And lastly, based on our current operating plans and expected access to additional equity financing, Ampio expects to have cash and cash equivalents along with access to external sources of liquidity sufficient to fund research and development programs and business operations through the fourth quarter of 2022. And now, I'll turn the call over to Mike Macaluso, Ampio's President and CEO, who will provide a corporate update on the overall business operations.
Mike Macaluso: Thanks, Dan. I mean, I understand there's pressure on our sector and more pressure on our stock. Let me share some positive truth on what's going on here. What is the status of AP-013 OAK Phase 3 study? Consistent with our ongoing public communications, the OAK trial was paused in April 2020, because of COVID-19. Since then, we have worked diligently with the FDA to gain better understanding of our viable options to preserve the study results to-date, which include keeping the special protocol assessment SPA in place. One, by adding more patients after the pandemic is over; or two, implementing the sensitivity analysis, which is basically a mathematical formula to minimize the impact of COVID-19. I have gone back and forth on which option to select, and the circumstances and timing associated with that decision. We have decided to proceed forward and unblind the study utilizing the sensitivity analysis to eliminate any bias from the pandemic. And I'll let Holli give you more details on this in a few minutes. The next question is timing. When are we going to do this? We have decided to do this as soon as the data has been properly cleaned and validated, meaning all queries have been addressed and answered. And the patient response data is properly reflected into database. That's a requirement of the FDA. Ordinarily, this process takes several months. The ongoing pandemic has continued to add complexity towards completing this process, including the collection of data. After spending -- already spending many months, and incurring considerable cost, we expect to have this quality control or clean data validation process finished later this quarter. And I'll give you a better clarity of the timing of the annual meeting, but hopefully August -- early September, we'll be done with that. But I'll update at that time. The validation process finished later this quarter with results released to the public shortly thereafter. Those results will be unblinded and shared with the public, interested parties who would that be, potential partners and later with the FDA. Of course, the FDA requires much more detailed investigative paperwork. So just again to clarify, again, we will run the clean data through the mathematical filter. And at that point, the blinded data will be unblinded and we'll share it with the public. I think that's pretty clear. Okay, now let's move to the Phase II inhaled Ampion study AP-019. Recall several weeks ago, we announced that we received regulatory approval to expand the enrollment of AP-019 Phase II study to India. As noted in the press release, India is not a separate trial, but rather an extension of the inhalation study that has already started in multiple hospitals in the United States. Some of you may have been asking me, Mike, what's taking so long? Of course, I asked the same question every day. But in actuality, the response is simple. It's not taking any excessive length of time. India similarly, the United States has very lengthy regulatory process similar to that of US as it relates to getting the hospital clinical site under contract, which includes receiving approval for clinical trials to be conducted, as well as regulating the sale and importation of drugs for the use of clinical trials from the Drug Comptroller General in India. Like the US, this process can take four or five, six months to get completed. The good news is we started this months and months ago, including the appropriate regulatory and import filings. In addition, we also needed agreement from the FDA to accept the clinical data from India for inclusion in the overall clinical -- and in the overall clinical trial results, so that we could apply it to an emergency use application, and eventually approval before we started the process. So before we could even think about India, we had to get the FDA to accept the clinical data we receive there. We receive confirmation in writing from the FDA to proceed. We currently expect to run this trial in 7 to 10 hospital sites in India and finish enrollment, even with the slow start faster than we would have if we focus the entire trial in the United States. So the purpose of going to India and rolling 7 to 10 hospitals will give us a result much quicker, if we then -- if we just did in United States. As previously stated, the Phase II inhalation study is already treating patients. So that India study is an extension of what we've already -- what we're already doing, as are the Phase II IV, and the long-haul of studies. All these previously referenced studies are listed on clinicaltrials.gov. On clinicaltrials.gov we estimated completion by December of this year. Now, obviously, with the addition of those sites, it will go sooner or take longer, we'll update that as we go along. But it's right now, sort of, stick with that. Also Ampio recently engaged a global strategic advisory firm to assist us with our partnering objectives. Consistent with previous communications, we continue to be engaged in ongoing discussions, and will expect these discussions to continue. And this is a new group, by the way, a very scientifically focused group. This is not the group we had before helping us. And they will focus on OAK, of course, but also on OA, and also in inflammatory conditions to simplify the whole platform and the turnkey opportunity. So this is a new group for us to help us do what we're trying to do. One of the questions I continually get asked is what is the expected timeframe to find the right partner or set of partners from both the domestic and global perspective? We asked the experts that are engaged in seeking and executing the partnerships, and I received basically the same consistent response is that I would expect. Simple, right? However, long it takes to find the right partner that sees the benefit of the platform and provides a deal structure that we're willing to accept. And while we're going through these partnering, this partnering process or discussions, we continue to add evidence of the platform potential, so that there's no slowing down. So I'll let Holli, sort of, update you more clinically on what's going on and specifically with the trials, and then I'll pick up at the end.
Holli Cherevka: Thank you, Mike. Thank you, everyone for joining us today. Now let's walk through the details of the updates Mike just provide. As the Wall Street Journal reported in July of this year, we are nearly 1.5 year into the COVID-19 pandemic, and researchers are still struggling to find effective, easy-to-use drugs to treat COVID-19. The COVID-19 public health emergency has disrupted clinical trials, medical practice and patient care with unprecedented impact. But by definition, a public health emergency in and of itself is an extraordinary event, which is determined to constitute a public health risk through the spread of disease and potentially requires a coordinated international response, which implies a situation that is serious, unusual or unexpected and carries implications for public health beyond the affected states national border, and may require immediate international action. This has clearly been true for the Ampion clinical programs. Ampion is currently positioned as the first novel mechanism of action in osteoarthritis of the knee for OAK in quite literally decades. To our knowledge, Ampion is also the latest phase development asset in OAK. As such, we have worked closely with the FDA on the development path for Ampion and receive detailed guidance from the agency on the steps needed to move the program forward during the COVID-19 public health emergency. Additionally, the FDA recently published a sensitivity and supplementary statistical analysis guidance in May of this year. We've incorporated this feedback into our approach with the OAK program and will perform a sensitivity and supplementary analysis to account for the impact of the COVID-19 public health emergency on the OAK clinical trial. And we expect to report those results to the public as soon as they are available. Many of our clinical sites utilized for the OAK study have opened while study monitors personnel to verify the data that is entered into our clinical space for analysis and presentation to the FDA. Such that on-site visits are now occurring and we are steadily moving forward to verify or clean the clinical data for analysis. Once that activity is complete, the data will become frozen or locked such that no additional changes will be made to the data entry from sites or patients and the data will be ready for analysis. We look forward to analyzing the data and the timeline Mike just provided. Simultaneously, our active research and development team correctly identified an application for the anti-inflammatory mechanism of Ampion in COVID-19 patients. We reported that a Phase I study of inhaled Ampion reduced all cause mortality by nearly 80% in hospitalized COVID-19 patients compared to standard-of-care treatment alone. This improvement was seen across clinical – including an improvement in oxygen use and decreased length of hospital stay. This data was presented to the FDA for guidance’s potential Emergency Use Authorization or EUA. The FDA provided detailed feedback on a Phase II clinical study for inhaled and for intravenous or IV Ampion treatment for COVID-19 patients. Both studies are actively enrolling patients in the United States as Mike just discussed. Additionally, the FDA approved the expansion of inhaled Ampion to clinical sites in India. The company has engaged the global care – support expansion into India and is actively working with the Indian Regulatory Body, the Drugs Controller General of India or DCGI, on the inhaled Ampion program for COVID-19 patients. We expect this expansion to shorten the timeline for overall study enrollment and potentially assist one of the world's highest density population of COVID-19 infections. At the same time, we were actively developing inhaled Ampion’s for at home use and have launched and are enrolling long COVID patients in a Phase 1 study of at home inhaled Ampion. As reported in Nature Biotechnology in July, there is no known effective treatment for long COVID, which presents a potentially large untapped market and treatment gap. Ampion has a novel mechanism of action, which makes it uniquely positioned as a potential treatment for long COVID. Additionally, as we continue to present the implant data in scientific forums in peer-reviewed journal. Next month at the 63rd annual Thomas L. Petty Aspen Lung Conference, Ampio will present in-vitro studies that indicate Ampion regulate cellular transcription to reduce inflammatory cytokines, such as tumor necrosis factor alpha, IL-1 beta, interferon-gamma, IL-6 et cetera, along with the recently completed Phase 1 clinical trial results of inhaled Ampion versus Standard of Care alone COVID-19 patients. Prior to launching this initial study in humans, Ampio undertook preclinical research to establish the safety of inhaled anti-inflammatory Ampion treatment. The FDA identified the need to assess the no observed adverse effects level in animals with Ampion via inhalation as the intended route of administration. The company was able to work with the FDA to design, perform and assess the potential local toxicity to the lung and other respiratory tissue at a range of inhalation doses in a study. The company will present this data at the American College of Toxicology 42nd Annual Meeting in November. As a platform therapy with a novel mechanism of action Ampio may have application in several inflammatory diseases. In October at the 14th International Congress on Systemic Lupus and 6th International Congress on Controversies in Rheumatology and Autoimmunity. Ampio will present evidence that treatment utilizing Ampion suppresses Toll Like Receptor 7/8 signaling in monocytic/macrophage lineages and suggests a role for Ampion in treating the dysregulation of these pathways observed in lupus. I will now turn the call back over to Dan, who will moderate questions and answers.
Dan Stokely: Thank you, Holli. Catherine, do you want to go ahead and give directions again for Q&A?
Operator: Certainly, ladies and gentlemen, the floor is open for questions. I would now like to turn the floor back to Dan for questions.
Dan Stokely: Thank you, Catherine. I did receive a set of a few questions from Jonathan Aschoff from Roth Capital. He was not able to make the call today. His first question and possibly Holli maybe you can give a response to this one. As the Delta variant and/or the vaccine hesitancy led to an increase in the rate of your COVID trial enrollment?
Holli Cherevka: You know Dan for the Wall Street Journal and an article just published last month. Quote, nearly a year and a half into the pandemic, researchers are still struggling to find effective, easy to use drugs to treat COVID-19. 10 drugs has been cleared or recommended in the U.S. for use. Two of those later have their authorizations rescinded after they failed to work. It's pretty staggering. Further, Dr. Janet Woodcock, Acting Director of the FDA stated, we had 10s of 1,000s of people hospitalized around the country who were not getting enrolled into clinical studies. American trials are often labor intensive and time consuming, requiring doctors to collect reams of data from patients. Contrary to popular belief, enrollment is not made easier and there are several regulatory hurdles that must be overcome to provide patients access to care. We are working diligently to ensure Patients have access to Ampion clinical trials. And we were actively conducting COVID trials and several hospitals across the country.
Dan Stokely: And the next question you had is the currently lower death rate from COVID versus the higher rate that was more than six months ago, complicating your ability to evaluate the mortality anymore.
Holli Cherevka: A lower death rate has always been the goal. The Ampion study is designed to evaluate mortality. And it also looks at oxygen use, hospital length of state and overall clinical improvement. This study examines these endpoints in hospitalized patients, meaning, we are still looking at severe and critical patients. The CDC reported that is late of March of this year, more than 40% of ventilated patients are not surviving, which is an astounding rate. In July of this year, a case study by the Washington Post, showed that for example, Missouri's case rate among unvaccinated people is as high as its overall case rate in mid-January, near the state's peak of infection. Additionally, in this article, we'll post adjustments vaccinations revealed the rate among susceptible unvaccinated people is 91% higher than the unadjusted case rates reported on Coronavirus websites in state tracking system. Without adjustment the national case rate for unvaccinated people is roughly the same as the unadjusted rate was more than two months ago and it's rising. The National adjusted hospitalization rate has climbed two points in last seen in April and the death rate is comparable to Mays on adjusted figures. The article goes on to say that even though treatments are better than they were originally, a larger share of patients are ending up in intensive care. And the fatality rate for those patients remains high as stated by experts. Those are the patients currently enrolled in the in some clinical trials.
Dan Stokely: Very good. And for this one's, what you need to do to be comfortable viewing the unblinded Phase III of data to the potential partner, not material?
Holli Cherevka: Well, we're unblinded Dan so or Jonathan, who ask question, Jonathan, we're unblinding the data. So we believe that good data will expand and escalate the interest. So we're unblinding the data and ASAP. It's no longer something we're weighing. It's happening. And we're going to do it as soon as possible.
Dan Stokely: Great, thank you, Catherine, next question. Operator: Your next question is coming from Jim Molloy with Alliance Global Partners. Your line is live.
Jim Molloy: Hey, guys, thanks. Take my question. Could you walk me through? Like if you'd hear your voice? So can you please walk me through sort of the unblind or continue to trial, the cost benefit that you went through? We talked about it the other day, but so your thoughts on we came to find the scene to unwind move forward to sort of walk through the, how you came to that? And that is the question.
Holli Cherevka: Okay, we were -- Jim, we were kicking it around back and forth, whether we should wait to unblind. It's sort of – we have the biggest block of KL4 patients that we know of that exists in the world in our historical data. Now that historical data is all one injection of Ampion, all KL4 patients, all randomized against CLE . That's the biggest block of data. That includes every patient we've ever treated. And that data is excellent. So now we have a similar sized trial that's sitting there blinded, that it's sort of like the elephant in the room, when we're having our discussions. And rather than talk hypothetically to people, because I believe the data is going to be good based on not optimism, but historically, every trial we've ever done using those patients has been effective and safe. I believe unblinding that data is going to help us create more interest and escalate what we're doing. It's complicated because the sensitivity analysis and guidance from the FDA has been ongoing. So it's not like we're working with guidance we received a year ago, we're actually just received guidance, I think at the end of May, give or take a day or two. That really pushed us to help us make that final decision. So anyway, the data that we're going unblended. I'm looking forward on blinding it and sort of taking that elephant out of the room. So we're in discussions and also for our shareholders to be able to say, okay, this is -- this will be the fifth or sixth or seventh trial we've passed, which if -- if I'm correct in making the statement, is more than all the currently approved drugs put together past. We're in a very difficult division, the OTAC Division of CBRE. So their requirements are much higher. But hopefully with good data, this will be enough to put us over the threshold. And move us forward. So I didn't really understand that whole part of your question. I talked a lot, I hope I answered it.
Q – Jim Molloy: Yes. you came to the decision to attend live and go forward with that call, and then just – could you talk a little bit about, I was hoping that good data obviously, we're hoping that as well. Can you walk through what's good versus bad data we expect to see, what’s the equivalent data and what’s the clinically meaningful improvement you anticipate to see or hope to see on your unblinded data?
Holli Cherevka: Yes, well, I hope to see statistical significance. But also I would be happy with a very, very strong trend. Remember, the trial was supposed to be 1,000 to 1,500 patients. I don't know exactly how many patients when to pass through the filter, until all the data is cleaned. My hope is that we have a similar number, if not a little bit larger than our store data. And therefore, we should have – could have should have enough evidence to show superiority, enough patients. So it really is just about being better than the placebo having a safe drug. And remember, there is no approved. There's nothing that compare us to. It's not like we could look at steroids or hyaluronic acids is a competitor, because they're not approved to treat the KL4 patients. So we're sort of in rare air by ourselves. Our goal, obviously, is this statistical threshold. And I'd be very happy with that, but also happy with a strong trend, and that's positive, and that the trial is about a third the size of what it was planned to be.
Q – Jim Molloy: Great. And last question for me. You talked about next steps, I guess, assuming good data than I guess maybe assuming equivalent data next steps for the drug for Ampion?
Holli Cherevka: Yes, you know what, I don't -- I hope that's not our decision, what we're going to do. Our goal was never to commercialize this drug ourselves. Our goal was to put this in the hands of someone, hopefully, with worldwide distribution. That's been our goal all along. Those are the discussions we're having. So I'd like to put that in the hands of a partner that has global representation. And let that be will manufacture the drugs and those marketed and sell it.
Jim Molloy: Great. Thanks for taking the questions.
Mike Macaluso: You bet.
Dan Stokely: Catherine, let me take a few off the web, few Q&A. First question I have is, Holli for you? Do we have a realistic timeline on when we'll be able to start distributing Ampion in India?
Holli Cherevka: Distributing Ampion in India, so I believe you're referring to when we're able to begin dosing stations in India under our current clinical trial. So the steps to move forward to do that we've already identified the sites, we've already applied for an import license for clinical drugs. And now we need the Drugs Controller General of India with whom we will be meeting shortly to bless the study such that we can move forward. So we believe we'll be dosing this quarter. Mike, anything to add?
Mike Macaluso : Yes, I mean, the sooner the better. And there's a lot of steps that were involved in, we've covered most of them. What we need is an import license to send our drug. The hospitals are picked, there's a lot of hospitals, there's still a lot of work has been done. It's a matter of getting that done, and we're on the agenda that could happen anytime within the next week or so to get that done. So, as soon as possible. I wish I had a better answer, but I don't control. We don't control this. Soon as we can, we're getting started. But we're all ready to ship the drug. Everything is packaged. We have the equipment. We have the nebulizers, all that's been ordered. It's here. It's boxed. All we need is a number to put on and it will go, So ASAP.
Dan Stokely: Great. Thank you. Another question. I'll go ahead and answer this one. Any other potential partners if you enter into a partner relationship provide funding for Ampion? You know, funding or monetizing the platform is obviously part of a deal negotiation. And obviously, partnering is different than M&A. Typically, under a partnering type of an arrangement, you'd seek some level of an upfront and milestones and royalties. So that's the best I can answer that question. And if and when as talks materialize, we’ll be sit on that. But obviously, a path that we're looking for non-dilutive capital that has to be at the right price. Another question here, you give any more clarity provided on the lupus treatment?
Mike Macaluso: Dr. B.
David Bar-Or: What is the question on lupus?
Dan Stokely: Can you please expand on the application of lupus…
Mike Macaluso: Okay, yes. So lupus is an autoimmune disorder. And one of the dreaded complication is what we call lupus nephritis, which is some kind of damage is inflammation of the kidney, or it leads to renal insufficiency in dialysis, et cetera. And what we know about lupus is that, one of the transcripts are the factors involved is toll-like receptor 7. And its -- toll-like receptors are very specific receptors, fundamental in the innate immune system that when activated, do cause a cascade of inflammatory response. And we have identified that Ampio block -- Ampion blocks TLR7, almost by 90%, which is a great, great result that could be applied to patients with lupus nephritis. So we are in the phases now of doing the preclinical research work on that. We're looking at animal models of lupus. And when we have results, we'll be able to convey to you. We are presenting at one of the large immunology and lupus meeting in abstract a paper we wrote on the subject.
Dan Stokely: Thank you. Question here for Mike. Assuming you were to get EUA, how soon would you be in a position to produce products?
Mike Macaluso: Immediately. Our factory is geared up? This is a good question. Because we've been saying to people that our factory had capabilities beyond just making vials. So we could make anything, we used to say that. And people -- pharma would say to me, prove it. And I would say, well, it's just obvious, right? We know we could do it, but I didn't have proof. The opportunity for us to just transition from OAK vials into IV, we started making it, i.e., filling the IV bags and then the nebulized version, the snap-off caps. It was interesting because pharma want to know how we can make that transition so quickly. And we made it within a couple months, where ordinarily you would be -- that would take a year or so. So like everything we do, we do it really, really quickly. And I believe very well. So we're ready to go. I mean, we're -- we have IV bags made, we have vials made. And we have the snap-off things made for the nebulizer. And with emergency use, obviously, we have to increase production. But we'll do that really quickly.
Dan Stokely: And Mike, I think that it on the questions. You want to provide some closing remarks?
Mike Macaluso: Sure. We have a lot going on with a handful of people. It's amazing what we accomplish. We have three clinical trials going right now, in multiple states and countries. We have quality discussions going on with pharma. What does that mean? It means that the first thing pharma looks at when they come into our data room is the data, right? That's what they look at. Is our data good? Is it good enough? Does it -- is it what they're looking for? I can tell you, if they don't like the data, that's a one day in and out of the data room, and they're gone. That's never happened. So then the next thing they're looking at is the FDA correspondence. Does the FDA correspondence tied to our data and tied to what we said publicly. Again, if there's complications with that they’re out of the data room. It goes on from there to manufacturing, to commercial opportunities, etcetera, etcetera, etcetera. We’ll bore you with all this. But we're having quality ongoing discussions with pharma and that's important. And we think with our new group, that's only going to improve, where we have multiple presentations as Holli referred to, toxicity and lupus. Why is that important? Because it adds credibility and substance to the platform. We don't want to talk about just awaking anymore. We want to talk about OAK and a platform technology and everything we're doing supports that. Of course, the unblinding of the data under FDA guidance, that's no small task. The sensitivity, I couldn't even read you, the formula for the sensitivity analysis, it looks like something Einstein would have on a major board, right. So, we're running all of our data through that. It's complicated, but we're in the process now of finalizing that. We have cash, so we're not desperate to get a deal done. We're in a good position there. And Dr. Bar-Or's research that's ongoing on rare children's diseases, and inflammatory kidney disease, animal studies that are coming up to support that; all those things we're doing, again, support the platform technology. So, there's no one sitting here moseying along, trying to figure out taking our time. We're sprinting, we're moving quickly. We're being fast. We're being quick. But as the Great John Wooden said, we don't want to be in a hurry. So, we're taking our time as we quickly get things done. So, I'm proud of what we're doing, what we're accomplishing. We're making progress every day to accomplish our hand and that's where we are. So, thank you for the time today. And if you guys have any other questions that you forgot or we didn't get to, email us and we'll be happy to answer them.
Operator: Thank you. Ladies and gentlemen, this concludes today's event. You may disconnect at this time and have a wonderful day. Thank you for your participation.
